# K242488: Soteria E-View

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, LLC
- Decided: Jan 6, 2025 after 138 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K912470 (1991). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212336: Soteria.AI, Omega Medical Imaging, LLC (2021) Summary page 5.

## Indications for use
The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.

Source page: https://510kreport.com/device/K242488
Methodology: https://510kreport.com/methodology